Randstad Life Sciences is seeking a Process Engineer III to join one of our client's engineering teams within a growing, FDA-regulated pharmaceutical manufacturing environment. This individual will play a key role in the development, scale-up, and validation of novel drug delivery products, supporting both commercial and developmental production.
location: York, Pennsylvania
job type: Permanent
salary: $95,000 - 110,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead the development and optimization of pharmaceutical manufacturing processes (mixing, coating, slitting, finishing).
- Collaborate cross-functionally with R&D, Quality, Operations, and external clients.
- Author and execute experimental protocols and process validation documents in compliance with cGMP (21 CFR 211).
- Analyze process data using statistical tools (DOE, SPC, ANOVA, regression) and support decisions with data-driven insights.
- Generate technical documentation, design records, and reports to support regulatory and commercial readiness.
- Troubleshoot process issues and lead root cause investigations.
- Provide technical direction and support to manufacturing teams during development, scale-up, and validation activities.
- Mentor junior engineers and assist with cross-training within the department.
qualifications:
- Bachelor's degree in Engineering (Chemical preferred); other technical disciplines will be considered with relevant experience.
- 5+ years' experience in a cGMP-regulated manufacturing environment.
- Prior supervisory or leadership experience preferred.
- Proficiency in statistical analysis, experimental design, and process optimization.
- Familiarity with regulatory filing elements (e.g., CMC), QbD, PAT, and Lean manufacturing principles.
- Strong interpersonal, presentatio and documentation skills.
- Ability to travel up to 25% and work flexible hours based on production needs.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
